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ProctiGard™ is indicated for the symptomatic management of rectal mucositis.

ProctiGard™ is a viscous, mucoadhesive liquid supplied in plastic bottles and is designed for the symptomatic management of rectal mucositis. When gently applied via the enema bottle applicator, the mucoadhesive formulation results in the formation of a protective coating over the rectal mucosa.

This 510(k) premarket notification is for ProctiGard™, a device indicated for the symptomatic management of rectal mucositis. The submission asserts substantial equivalence to a predicate device, MuGard® Mucoadhesive Oral Wound Dressing (K062795).

Here is an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not describe a clinical "test set" or a clinical study involving human subjects for ProctiGard™. The device's substantial equivalence is primarily based on the identical composition and analogous mode of action to its predicate device, MuGard®, along with preclinical biocompatibility testing. The data provenance for the biocompatibility tests (guinea pigs, rabbits) is not specified geographically or as retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set involving human subjects requiring expert ground truth establishment is described in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. ProctiGard™ is a medical device (a protective coating), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. ProctiGard™ is a medical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's claims of safety and effectiveness relies on:

• Identity of Formulation: The chemical and physical composition of ProctiGard™ is stated to be identical to the legally marketed predicate device, MuGard®.
• Biocompatibility Standards: Compliance with ISO 10993 standards (in vitro cytotoxicity, sensitization, mucosal irritation in animal models) serves as the "ground truth" for safety.
• Analogous Mode of Action: The understanding that a protective layer over mucosa provides symptomatic relief, which was established for the predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The basis for approval is substantial equivalence to a predicate, supported by preclinical biocompatibility testing and identical formulation.

9. How the ground truth for the training set was established

Not applicable. No training set is described.

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MuGard™ Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.

MuGard™ Mucoadhesive Oral Wound Rinse is a viscous liquid supplied in plastic bottles and is designed for the management of oral mucositis/stomatitis and other oral wounds. When swirled gently round the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa.

This document describes a 510(k) premarket notification for the MuGard™ Mucoadhesive Oral Wound Rinse.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in terms of device performance metrics (e.g., specific reduction in pain score, healing time). Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices through:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a specific clinical study with a test set of human subjects to quantify performance metrics. The safety of the device was established through biocompatibility testing, which typically involves laboratory animal studies (guinea pigs, rabbits) and in vitro tests. No information on human test subjects or data provenance (country, retrospective/prospective) is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Since no clinical study with human subjects or a test set is described for performance evaluation, this information is not applicable. The device's safety was assessed through standard biocompatibility tests, not by expert interpretation of clinical outcomes for ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a comparative study against human readers or other treatments.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a medical product (oral rinse), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the device's acceptable performance is established through:

• Demonstration of substantial equivalence to legally marketed predicate devices.
• Biocompatibility testing results (e.g., negative for cytotoxicity, sensitization, and mucosal irritation).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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